Back to resultsChinese Tuina Therapy for Treatment of Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese Tuina therapy
Physical Manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Arthritis, Massage, Tuina, Traditional Chinese medicine, Physical therapy, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, manual therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of KOA;
- Age 40-75 years;
- KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
- NRS score of pain at least more than 4 points;
- Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on both legs, the heavier leg is selected for study.
Exclusion Criteria:
- Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
- Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
- Oral administration of hormones within 3 month, intra-articular injection within 6 months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1 year.
- Severe acute/chronic organic or mental diseases;
- Pregnant women, pregnant and lactating women;
- Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
- Device support treatment after knee osteoarthritis disability;
- Participation in another clinical study in the past 3 months;
- History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
- Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
Sites / Locations
- Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chinese Tuina group (CTG)
Physical Manual group (PMG)
Arm Description
The participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise.
The participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise.
Outcomes
Primary Outcome Measures
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
Secondary Outcome Measures
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
Change in Numeric Knee Pain Rating Scale
Subjects will rate their worst knee pain in the last 24 hours using an 11 point numeric pain rating scale with 0 representing "no pain" and 10 representing " the worst pain imaginable".
Change in Patient Global Assessment (PGA)
The Patient global assessment rating is a 11 point Numeric Rating Scale in which subjects will rate the degree to which their knee condition has changed from the time treatment was initiated to the present. The subject responds to the following query: "Please rate your overall knee's condition from the time you began treatment until now." using an 11 point numeric rating scale with 0 representing "A very great deal better" and 10 representing "A very great deal worse".
Change in 12-item Short Form Health Survey (SF-12)
The SF-12 is a generic health-related quality of life measure.
Change in 30 second time chair rise test
Subjects will be seated with their arms crossed in front of their chest. On the command "go" subjects will stand up and sit down for as many trials as they can in a 30 second period.
Change in Timed Up and Go Test Time
On the command "go" subjects will stand up from a chair, walk 3 meters, turn around, return to the chair and sit down. The time it takes to complete this task will be recorded.
Change in One Leg Standing Test
One single-leg standing was assessed balance. Test required the subject to stand with arms by his/her side.Timing was started when the subject raised one foot off the ground. Timing was stopped if the subject displaced the weight-bearing foot, touched the suspended foot to the ground, used the suspended limb to support the weight-bearing limb, or reached the maximum balance time of 30 seconds.
OARSI Responder Criteria
Responder criteria included 1) greater than or equal to 50% improvement in WOMAC pain or WOMAC function and an absolute improvement of greater than or equal to 20, or 2) improvement in at least 2 of the following 3 scores: 20% improvement in pain and absolute change ≥ 10 on WOMAC pain score, 20% improvement in pain and absolute change ≥ 10 on WOMAC function score, or moderate or greater improvement (≤ 4) on a 15 point global rating of change scale
Blinding assessment
To test whether the participants are blinded successfully, all participants will be asked to guess which kind of treatment they received.
Credibility/Expectancy Questionnaire
The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire
Rescue medicine
Any use of pain-killers will be ascertained.
Adverse events
Adverse Event Form
Full Information
NCT ID
NCT03966248
First Posted
May 26, 2019
Last Updated
February 3, 2023
Sponsor
Beijing University of Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03966248
Brief Title
Chinese Tuina Therapy for Treatment of Knee Osteoarthritis
Official Title
Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2019 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious pain, joint stiffness, limitation of activity and even disability, with significant associated costs and effects on society, health systems, and individuals. Tuina therapy has been used and showed effectiveness and safety for pain relief and disability for the patients with musculoskeletal disorders for years in China. Though it is regarded that the Traditional Chinese medicine (TCM) Tuina therapy is similar to the modern manual therapies, the modalities of TCM tuina therapy are different and effect maybe equal to or more better than the modern manual therapy in clinic. However, little evidence exists that Tuina benefits the KOA. The investigators will do this in a randomized, parallel, active controlled study to observe whether TCM Tuina is more beneficial to KOA than the physical manual therapy, which has been considered an effective and standard care for KOA.
Detailed Description
Patients will be randomly allocated to one of two groups. In the Chinese Tuina group (group CTG), patients will receive the traditional Chinese Tuina therapy (including rolling, grasping, scratching, pressing, acupressure or pushing) on the basis of KOA health education and home-exercise. Patients in the Physical Manual group (group PMG) will receive the modern physical manual therapy (including joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching, range of motion and strength training) on the basis of KOA health education and home-exercise. Assessments will be conducted at baseline and 4 and 16 weeks after randomization.
It is expected that the interventions will alleviate the sufferings of the patient. The risks of participation are minimal. Occasionally, tuina can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects happen during and after Tuina or manual treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Arthritis, Massage, Tuina, Traditional Chinese medicine, Physical therapy, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms recruit and evaluate the participants at the same time, and the included participants have the equal opportunity to either the Chinese Tuina or physical manual therapy groups.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants are randomly divided into Chinese Tuina group and Physical Manual group at a ratio of 1:1, only knowing that they will receive the manual therapies. The assessor, data manager and statistician will not participate in the randomized process and the treatment and share any information with each other.
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chinese Tuina group (CTG)
Arm Type
Experimental
Arm Description
The participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise.
Arm Title
Physical Manual group (PMG)
Arm Type
Active Comparator
Arm Description
The participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise.
Intervention Type
Other
Intervention Name(s)
Chinese Tuina therapy
Intervention Description
The doctor presses the affected lower limb from the anterior superior iliac spine to the ankle;
The doctor gives the pressure on the Biguan(ST31), Futu(ST32), Heding(EX-LE2), Neixiyan(EX-LE4), Waixiyan(Dubi, ST35), Zusanli(ST36) and Sanyinjiao(SP6) of the affected lower limb;
Massage the spleen and stomach meridians of the affected lower extremes;
Roll the soft tissues around the affected knee;
Relax the gastrocnalis muscle
The doctor gives the pressure on the Xuehai(SP10), Liangqiu(ST34), Neixifeng(medial patellofemoral ligament), Waixifeng(lateral patellofemoral ligament), Neixiyan(EX-LE4) and Waixiyan(Dubi, ST35) at the same time;
Push the patella and do the passive movement of the affected knee;
Strength training of the affected knee.
This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email.
Intervention Type
Other
Intervention Name(s)
Physical Manual therapy
Intervention Description
Manual therapy: Stretching the knee joint, stretching the knee joint with valgus or abduction, stretching the knee joint with varus or adduction is suitable for patients with knee flexion and extension difficulty.Patellar manipulation by bending the knee 5-10 degrees downward is suitable for patients with patellar sliding difficulty.The lower end of the muscle length manipulation is suitable for patients with muscle tension and soft tissue tension.Soft tissue loosening is performed in the suprapatellar and peripatellar regions, medial and lateral capsule joints, and popliteal fossa.
Activity training: Mainly about the knee joint flexion and extension movement training.
Strength training: Mainly about quadriceps muscle resistance exercises
This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email.
Primary Outcome Measure Information:
Title
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
Time Frame
Change from baseline at 8 weeks and 16 weeks
Title
Change in Numeric Knee Pain Rating Scale
Description
Subjects will rate their worst knee pain in the last 24 hours using an 11 point numeric pain rating scale with 0 representing "no pain" and 10 representing " the worst pain imaginable".
Time Frame
Change from baseline at 4 weeks, 8 weeks and 16 weeks
Title
Change in Patient Global Assessment (PGA)
Description
The Patient global assessment rating is a 11 point Numeric Rating Scale in which subjects will rate the degree to which their knee condition has changed from the time treatment was initiated to the present. The subject responds to the following query: "Please rate your overall knee's condition from the time you began treatment until now." using an 11 point numeric rating scale with 0 representing "A very great deal better" and 10 representing "A very great deal worse".
Time Frame
Change from baseline at 4 weeks, 8 weeks and 16 weeks
Title
Change in 12-item Short Form Health Survey (SF-12)
Description
The SF-12 is a generic health-related quality of life measure.
Time Frame
Change from baseline at 4 weeks, 8 weeks and 16 weeks
Title
Change in 30 second time chair rise test
Description
Subjects will be seated with their arms crossed in front of their chest. On the command "go" subjects will stand up and sit down for as many trials as they can in a 30 second period.
Time Frame
Change from baseline at 4 weeks
Title
Change in Timed Up and Go Test Time
Description
On the command "go" subjects will stand up from a chair, walk 3 meters, turn around, return to the chair and sit down. The time it takes to complete this task will be recorded.
Time Frame
Change from baseline at 4 weeks
Title
Change in One Leg Standing Test
Description
One single-leg standing was assessed balance. Test required the subject to stand with arms by his/her side.Timing was started when the subject raised one foot off the ground. Timing was stopped if the subject displaced the weight-bearing foot, touched the suspended foot to the ground, used the suspended limb to support the weight-bearing limb, or reached the maximum balance time of 30 seconds.
Time Frame
Change from baseline at 4 weeks
Title
OARSI Responder Criteria
Description
Responder criteria included 1) greater than or equal to 50% improvement in WOMAC pain or WOMAC function and an absolute improvement of greater than or equal to 20, or 2) improvement in at least 2 of the following 3 scores: 20% improvement in pain and absolute change ≥ 10 on WOMAC pain score, 20% improvement in pain and absolute change ≥ 10 on WOMAC function score, or moderate or greater improvement (≤ 4) on a 15 point global rating of change scale
Time Frame
At weeks 4 after randomisation.
Title
Blinding assessment
Description
To test whether the participants are blinded successfully, all participants will be asked to guess which kind of treatment they received.
Time Frame
At weeks 4 after randomisation.
Title
Credibility/Expectancy Questionnaire
Description
The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire
Time Frame
About 5 min after the first treatment
Title
Rescue medicine
Description
Any use of pain-killers will be ascertained.
Time Frame
At weeks 4, 8 and 16 after randomisation.
Title
Adverse events
Description
Adverse Event Form
Time Frame
At weeks 4 after randomisation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of KOA;
Age 40-75 years;
KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
NRS score of pain at least more than 4 points;
Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on both legs, the heavier leg is selected for study.
Exclusion Criteria:
Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
Oral administration of hormones within 3 month, intra-articular injection within 6 months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1 year.
Severe acute/chronic organic or mental diseases;
Pregnant women, pregnant and lactating women;
Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
Device support treatment after knee osteoarthritis disability;
Participation in another clinical study in the past 3 months;
History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiyou Wang
Organizational Affiliation
Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chinese Tuina Therapy for Treatment of Knee Osteoarthritis
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